On November 19, 2025, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to L Krenk DBA Maui Clinic Pharmacy of Kahului, Hawaii (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1, 6. The OSC proposed the revocation of Registrant's DEA registration, No. BL3161178, alleging that its continued registration would be inconsistent with the public interest. Id. at 1, 3 (citing 21 U.S.C. 823(g)(1), 824(a)(4)).

More specifically, the OSC alleged that Registrant and its owner, from March 2023 to July 9, 2024, violated federal and state law by dispensing controlled substance prescriptions from an unregistered location, and violated federal law by failing to comply with recordkeeping requirements as evidenced by “significant unexplained overages and shortages of controlled substances.” Id. at 4.

On April 16, 2026, the Government submitted an RFAA requesting that the Agency issue a default final order revoking Registrant's registration. RFAA, at 3. After carefully reviewing the entire record and conducting the analysis set forth below, the Agency grants the Government's RFAA and revokes Registrant's registration.

I. Default Determination

Under 21 CFR 1301.43, a registrant entitled to a hearing who fails to file a timely hearing request “within 30 days after the date of receipt of the [OSC] . . . shall be deemed to have waived their right to a hearing and to be in default” unless “good cause” is established for the failure. 21 CFR 1301.43(a), (c)(1). In the absence of a determination of good cause, a registrant who fails to timely file an answer also is “deemed to have waived their right to a hearing and to be in default.” 21 CFR 1301.43(c)(2). Unless excused, a default is deemed to constitute “an admission of the factual allegations of the [OSC].” 21 CFR 1301.43(e).

The OSC informed Registrant that it has a right to file a written request for hearing and answer, and that if it failed to file such a request and answer, it would be deemed to have waived its right to a hearing and to be in default.^[1] RFAAX 1, at 5 (citing 21 CFR 1301.43). Here, Registrant did not request a hearing or file an answer. RFAA, at 1-2. Further, the Agency notes that more than forty-five days have passed since the OSC was served on Registrant, yet the Agency has not received a motion by Registrant to be excused from default for good cause. 21 CFR 1301.43(c)(1). Thus, the Agency determines that Registrant is in default and, therefore, Registrant is deemed to admit the factual allegations in the OSC. 21 CFR 1301.43(c)(1), (e), (f)(1).

II. Public Interest Determination

A. Overview of Law

Congress enacted the Controlled Substances Act (CSA) “to conquer drug abuse and control the legitimate and illegitimate traffic in controlled substances.” Gonzales v. Raich, 545 ( printed page 64690) U.S. 1, 12 (2005). A particular concern of Congress was “the need to prevent the diversion of drugs from legitimate to illicit channels,” and it “devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.” Id. at 12-13.

The CSA requires, under this closed regulatory system, that “[e]very person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the [DEA] a registration.” 21 U.S.C. 822(a)(2); Gonzales v. Raich, 545 U.S. at 27-28. To protect the American people and ensure compliance with the CSA, Congress empowered the Agency to deny, suspend, or revoke a registration if granting or continuing a registration “would be inconsistent with the public interest.” 21 U.S.C. 823(g)(1), 824(a)(4); Gonzales v. Oregon, 546 U.S. 243, 251 (2006).

In determining whether a registrant's registration would be inconsistent with the public interest, the Agency analyzes five statutorily established “public interest factors.” Gonzales v. Oregon, 546 U.S. at 251; 21 U.S.C. 823(g)(1)(A)-(E). The five factors are:

(A) The recommendation of the appropriate State licensing board or professional disciplinary authority.

(B) The [registrant]'s experience in dispensing, or conducting research with respect to controlled substances.

(C) The [registrant]'s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

(D) Compliance with applicable State, Federal, or local laws relating to controlled substances.

(E) Such other conduct which may threaten the public health and safety.

21 U.S.C. 823(g)(1).

These five public interest factors are considered in the disjunctive. Gonzales v. Oregon, 546 U.S. at 292-93 (Scalia, J., dissenting); Robert A. Leslie, M.D.,68 FR 15227, 15230 (2003). Each factor is weighed on a case-by-case basis. David H. Gillis, M.D.,58 FR 37507, 37508 (1993). Any one factor, or combination of factors, may be decisive, Gillis, 58 FR at 37508, and the Agency “ `may give each factor the weight . . . deem[ed] appropriate in determining whether a registration should be revoked or an application for registration denied.' ” Morall v. Drug Enf't Admin., 412 F.3d 165, 185 n.2 (D.C. Cir. 2005) (Henderson, J., concurring) (quoting Robert A. Smith, M.D.,70 FR 33207, 33208 (2005)); see Penick Corp., Inc. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C. Cir. 2007). The Agency has taken this approach for decades. See Henry J. Schwarz, Jr., M.D.,54 FR 16422, 16424 (1989) (determining, in 1989, that “[t]he [Agency] need not make findings as to all of the factors . . . [and that the Agency] may give each factor the weight [it] deems appropriate,” and basing denial on only two factors); Neveille H. Williams, D.D.S.,53 FR 23465, 23466 (1988) (holding, in 1988, and citing a 1986 case, that “[a]ll factors need not be present for the [Agency] to” issue a sanction and that the Agency “may accord each factor the weight [it] deems appropriate in determining the public interest” (citing Paul Stepak, M.D.,51 FR 17556 (1986))).

While the Agency is required to consider each of the factors, it “need not make explicit findings as to each one.” MacKay v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011) (quoting Volkman v. U.S. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009)); Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir. 2005). “In short, . . . the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's misconduct.” Jayam Krishna-Iyer, M.D.,74 FR 459, 462 (2009). Accordingly, Agency decisions have explained that findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821.

The Government has the burden of proof in this proceeding, 21 CFR 1301.44(e), and the Agency must make its findings based on “substantial [record] evidence.” 5 U.S.C. 556(d); see5 U.S.C. 706(2); 21 U.S.C. 877. If the Government meets its burden of establishing a prima facie case that Registrant's registration is not in the public interest, then the burden shifts to Registrant to rebut the Government's case. Pharmacy Doctor Enters., Inc. v. Drug Enf't Admin., 789 Fed. Appx. 724, 729 (11th Cir. 2019) (citing Jones Total Health Care Pharmacy, 881 F.3d at 830).

In this matter, the Government's evidence is confined to Factors B and D. RFAA, at 1-3. The Agency considers evidence under Factors B and D when the evidence concerns Registrant's experience in dispensing controlled substances, and Registrant's compliance with applicable State, Federal, or local laws relating to controlled substances, respectively. See Ashraf v. United States, 153 F.4th 1161, 1160-70 (11th Cir. 2025); Kareem Hubbard, M.D.,87 FR 21156, 21162 (2022).

The CSA also addresses the role of states in the enforcement of its provisions. According to 21 U.S.C. 903, “Application of State law,” “[n]o provision of . . . [Subchapter I] shall be construed as indicating an intent on the part of the Congress to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this subchapter and that State law so that the two cannot consistently stand together.” 21 U.S.C. 903 (the CSA's non-preemption provision); Gonzales v. Oregon, 546 U.S. at 270-71.

The ramifications of the CSA's non-preemption provision are significant for the Agency's enforcement of the CSA. As the Supreme Court explains in Gonzales v. Oregon, in the context of physicians dispensing controlled substances, the CSA and Supreme Court case law “amply support the conclusion that Congress regulates medical practice insofar as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood.” Id. at 269-70. The Court continues, explaining that, “beyond this, however, the . . . [CSA] manifests no intent to regulate the practice of medicine generally. The silence is understandable given the structure and limitations of federalism, which allow the States `great latitude under their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons.' Medtronic, Inc. v. Lohr, 518 U.S. 470, 475, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (quoting Metropolitan Life Ins. Co. v. Massachusetts, 471 U.S. 724, 756, 105 S.Ct. 2380, 85 L.Ed.2d 728 (1985)).” Id. at 270 (citation modified).

The Supreme Court also states that the “structure and operation of the CSA presume and rely upon a functioning medical profession regulated under the States' police powers.” Id. (citing the provisions of 21 U.S.C. 823(g)(1), formerly 21 U.S.C. 823(f), and pointing out that the “Attorney General can register a physician to dispense controlled substances `if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices' ”). Further, the Supreme Court states, “[w]hen considering whether to revoke a physician's registration, the Attorney General looks not just to violations of federal laws; but he `shall' also consider ( printed page 64691) `[t]he recommendation of the appropriate State licensing board or professional disciplinary authority' and the registrant's compliance with state and local drug laws.” Id. The Supreme Court also highlights the fact that the “very definition of a `practitioner' eligible to prescribe [controlled substances] includes physicians `licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices' to dispense controlled substances.” Id. (citing 21 U.S.C. 802(21)). Finally, the Supreme Court even presaged, cautioned against, and debunked, “conclusions that the CSA effectively displaces the States' general regulation of medical practice.” Id.

As the Supreme Court stated, “[i]n the face of the CSA's silence on the practice of medicine generally[,] and its recognition of state regulation of the medical profession[,] it is difficult to defend” a statement that state legal requirements for practitioners play no role in enforcement of the CSA. Id. at 272. Instead, the CSA's non-preemption provision means that, except for one instance, the CSA respects, and enforces, state laws regulating the professional actions of federal controlled substance registration holders.^[2]

As specifically relevant to this Registrant and this OSC, for example, the CSA's non-preemption provision means that Hawaii legal provisions concerning the dispensing of controlled substances from registered locations apply to Registrant along with federal dispensing of controlled substances from registered location requirements. Further, if the alleged violations of Hawaii law are established, they may contribute to a prima facie case for revocation of Registrant's registration. 21 U.S.C. 823(g)(1)(D).

B. Applicable Federal and State Law

The OSC alleges that Registrant (1) dispensed controlled substances from an unregistered location and (2) could not account for controlled substances. RFAAX 1, at 4.

As for the unregistered location allegations, the CSA's implementing regulations require every person to obtain a registration to dispense a controlled substance, absent an exemption. 21 CFR 1301.11(a). The CSA's implementing regulations also require a separate registration for each principal place of business where controlled substances are dispensed. 21 CFR 1301.12(a).

Similarly, Hawaii law requires a separate registration for each principal place of business where Registrant dispenses controlled substances. Haw. Code R. Stat. 23-200-10 (2000).^[3] Hawaii law also requires a Board of Pharmacy permit before operating, or changing the location of, a pharmacy. Haw. Rev. Stat. 461-14(a) (2008). Further, Hawaii law requires registered pharmacists in charge of a pharmacy to comply with all laws and rules, including a requirement to notify the Pharmacy Board within ten days of changes of business address. Haw. Rev. Stat. 461-11 (2001).

As for the unaccounted-for controlled substances allegations, the CSA's implementing regulations specify, among other things, requirements for inventories, including initial and biennial inventories.^[4] 21 CFR 1304.11 (a)-(c). The CSA's implementing regulations also state that registrants required to keep records shall maintain, on a current basis, a complete and accurate record of each controlled substance received, sold, or otherwise disposed of. 21 CFR 1304.21(a). Further, the CSA's implementing regulations state that inventory and other required records must be kept and be available for at least two years for inspection and copying by DEA employees. 21 CFR 1304.04(a).

C. Findings of Fact

In light of Registrant's default, the factual allegations in the OSC are deemed admitted and are proven by substantial evidence, indeed, proven incontrovertibly and unequivocally, as follows.^[5] 21 CFR 1301.43(e).

Prior to mid-March of 2023, Registrant's registered location was 53 S. Pruunene Street, Suite 120, Kahului, Hawaii 96732. RFAAX 1, at 4. In mid-March, Registrant ceased operations at 53 S. Pruunene Street and began operating from a new location at 22 Hana Highway, Suite B, Kahului, Hawaii 96732. Id. Prior to relocating, Registrant failed to inform the Hawaii Pharmacy Board and the State of Hawaii Narcotics Enforcement Board of its intent to move from the S. Pruunene Street location to the Hana Highway location. Id. Further, Registrant failed to notify the Hawaii Pharmacy Board of its new address within 10 days of the move. Id. Between April 1, 2023, and August 23, 2023, Registrant dispensed approximately 300 prescriptions for various controlled substances, including Schedule II opioids, from the new, unregistered location. Id.

For the inspection period of May 1, 2023, through July 9, 2024, Registrant had significant record keeping and inventory discrepancies, resulting in significant, unexplained overages and shortages of controlled substances. Id. at 4-5. Between July 9, 2024, and September 17, 2024, DEA collected the necessary documents to conduct an accountability audit of various controlled substances at Registrant for the period of May 1, 2023, through July 9, 2024. Id. at 4. The accountability audit revealed a significant number of record keeping and inventory discrepancies by Registrant totaling 4,779 unaccounted-for dosage units. See id. at 4-5. Of that total number, 1,804 dosage units are Schedule II (shortage of oxycodone 15 mg and overages of hydrocodone acetaminophen and oxycodone acetaminophen), 708 dosage units are Schedule III (shortage of buprenorphine/naloxone 8-2), and 2,267 dosage units are Schedule IV (shortage of alprazolam 1 mg as well as an overage of Tramadol). ⁶ See id. at 5.

D. Conclusions of Law

The Agency determines that the OSC's deemed-admitted factual allegations present prima facie cases that Registrant dispensed controlled substances from an unregistered location, in violation of 21 CFR 1301.11(a), 21 CFR 1301.12(a), Haw. Code R. Stat. 23-200-10 (2000), Haw. ( printed page 64692) Rev. Stat. 461-14(a) (2008), and Haw. Rev. Stat. 461-11 (2001). Supra Section II.C. The Agency further determines that the OSC's deemed-admitted factual allegations present prima facie cases that Registrant had unaccounted-for controlled substances, in violation of 21 CFR 1304.11(a-c), 21 CFR 1304.21(a), and 21 CFR 1304.04(a). Id.

E. Public Interest Conclusion

While the Agency considered all the public interest factors of 21 U.S.C. 823(g)(1), its determinations are relevant to Factor B (experience dispensing controlled substances) and Factor D (compliance with applicable State, Federal, or local laws relating to controlled substances). 21 U.S.C. 823(g)(1); Pharmacy Doctors, 789 Fed. App'x at 729-30, accord Jones Total Health Care Pharmacy, 881 F.3d at 829-30, Hoxie v. Drug Enf't Admin., 419 F.3d at 481-82; Kareem Hubbard, M.D., 87 FR at 21162. Accordingly, the Agency determines that, after considering the public interest factors, and the facts deemed admitted by virtue of Registrant's default, the Government satisfied its prima facie burden of showing that Registrant “has committed such acts as would render [its] registration under section 823 of this title inconsistent with the public interest.” 21 U.S.C. 824(a)(4). The Agency further finds that, in light of Respondent's failure to respond, there is no mitigating evidence to rebut the Government's prima facie case. Thus, the only remaining issue is whether revocation of Registrant's registration is the appropriate sanction.

III. Sanction

Where, as here, the Government presented a prima facie case that Registrant's continued registration would be inconsistent with the public interest, the burden shifts to Registrant to show why it can be entrusted with a registration. Morall, 412 F.3d at 174; Jones Total Health Care Pharmacy, 881 F.3d at 830; Garrett Howard Smith, M.D.,83 FR 18882, 18904 (2018). The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual registrant. Jones Total Health Care Pharmacy, 881 F.3d at 833; Jeffrey Stein, M.D.,84 FR 46968, 46972 (2019). Moreover, as “past performance is the best predictor of future performance,” the Agency requires that a registrant who has committed acts inconsistent with the public interest accepts responsibility for those acts, understands the gravity and seriousness of the misconduct, and demonstrates that the registrant will not engage in future misconduct. ALRA Labs., Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995); Jones Total Health Care Pharmacy, 881 F.3d at 831-33. The Agency requires a registrant's unequivocal acceptance of responsibility. Janet S. Pettyjohn, D.O.,89 FR 82639, 82641 (2024); Mohammed Asgar, M.D.,83 FR 29569, 29573 (2018); Jones Total Health Care Pharmacy, 881 F.3d at 830-31. In addition, a registrant's candor during the investigation and hearing, if one is requested, is an important factor in determining acceptance of responsibility and the appropriate sanction. Jones Total Health Care Pharmacy, 881 F.3d at 830-31; Hoxie, 419 F.3d at 483-84. Further, the Agency considers the egregiousness and extent of the misconduct as significant factors in determining the appropriate sanction. Jones Total Health Care Pharmacy, 881 F.3d at 834 & n.4. The Agency also considers the need to deter similar acts by a registrant and by the community of registrants. Stein, 84 FR at 46972-73.

Here, Registrant did not timely request a hearing or timely answer the allegations, and is, therefore, deemed to have waived its right to a hearing and to be in default. 21 CFR 1301.43(c)(1), (e), (f)(1); RFAA, at 1-2. Thus, there is no record evidence that Registrant takes responsibility, let alone unequivocal responsibility, for the founded violations. Further, the record evidence is that, on or about September 30, 2019, Registrant and the United States Attorney's Office for the District of Hawaii entered into a settlement agreement in which Registrant agreed to pay a fine and comply with the CSA and its implementing regulations. RFAAX 1, at 3. The existence of the OSC and this adjudication show that Registrant violated that settlement agreement. Accordingly, Registrant has not convinced the Agency that its future controlled-substance-related actions will comply with the CSA such that the Agency should continue to entrust it with a registration.

Further, the interests of specific and general deterrence weigh in favor of revocation. Registrant's founded violations concern the CSA's “strict requirements regarding registration” and, therefore, go to the heart of the CSA's “closed regulatory system” specifically designed “to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances,” and to the heart of the Agency's law enforcement mission. Gonzales v. Raich, 545 U.S. at 12-14. Registrant's egregious violations also involve dispensing controlled substances from an unregistered location, and a combined 4,779 unaccounted-for overages and shortages of controlled substance dosage units. If the Agency were to allow Registrant to maintain its registration under these circumstances, it would send an inaccurate message—that dispensing controlled substances according to minimal state standards and in compliance with state and federal law is not essential to maintaining a registration.

In sum, Registrant has not submitted any record evidence that rebuts the Government's prima facie case for revocation of its registration, and that convinces the Agency that it should continue to entrust Registrant with a DEA registration. The record, thus, supports the imposition of a sanction. Accordingly, the Agency will order the revocation of Registrant's registration.

Order

Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. BL3161178 issued to L Krenk DBA Maui Clinic Pharmacy. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny any pending applications of L Krenk DBA Maui Clinic Pharmacy to renew or modify this registration, as well as any other pending application of L Krenk DBA Maui Clinic Pharmacy for additional registration in Hawaii. This Order is effective November 9, 2026.

Signing Authority

This document of the Drug Enforcement Administration was signed on October 5, 2026, by DEA Administrator Terrance C. Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .